[2R-(2α,3Z,5α)]-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, compound with tert-butylamine (1:1)

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

other: Due to its nature, it proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals.

Adequacy of study:

key study

Study period:

testing was performed on the 11th March 2013.

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

In order to comply with regulatory requirements, work was carried out in an attempt to generate atmospheres of the test item. Had this work been successful, the study would have proceeded such that it would have complied with the method described in the OECD Guidelines for Testing of Chemicals (2009) No. 436 “Acute Inhalation Toxicity – Acute Toxic Class Method”.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

TBA Clavulanate

IUPAC Name:

TBA Clavulanate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Sponsor's identification : tBA Clavulanate
Batch number : 13c30367
Description : Off-white powder
Assay (O.A.B.S.F.) : 100.88 %w/w
Date received : 01 March 2013
Expiry Date : 11 February 2016
Storage conditions : Cold at approximately 4°C, in the dark over silica gel

Test animals

Species:

other: not applicable as no actual testing was conducted

Strain:

other: not applicable as no actual testing was conducted

Sex:

not specified

Details on test animals or test system and environmental conditions:

not applicable as no actual testing on animals was conducted

Administration / exposure

Route of administration:

other: not applicable as no actual testing on animals was conducted

Type of inhalation exposure:

other: not applicable as no actual testing on animals was conducted

Vehicle:

other: not applicable as no actual testing on animals was conducted

Details on inhalation exposure:

not applicable as no actual testing on animals was conducted

Analytical verification of test atmosphere concentrations:

not specified

Duration of exposure:

0 d

Concentrations:

not applicable as no actual testing on animals was conducted

No. of animals per sex per dose:

not applicable as no actual testing on animals was conducted

Control animals:

other: not applicable as no actual testing on animals was conducted

Details on study design:

not applicable as no actual testing on animals was conducted

Results and discussion

Effect levels

Remarks on result:

other: It proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals, therefore no actual testing was conducted.

Mortality:

Not applicable as no actual testing was conducted

Clinical signs:

other: Not applicable as no actual testing was conducted

Body weight:

Not applicable as no actual testing was conducted

Gross pathology:

Not applicable as no actual testing was conducted

Any other information on results incl. tables

Due to its nature, it proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Due to its nature, it proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals.

The dust generation properties of tBA Clavulanate with a particle size of less than 4 μm were shown to be low. It was, therefore, considered not to be possible to generate an atmosphere with a satisfactory particle size from the test item, for use in an inhalation study.

In view of the physical nature of the test item, its apparent low volatility and its’ tendancy to clump, it is considered unlikely to represent a significant hazard by the inhalation route.

Executive summary:

Due to its nature, it proved impossible to generate atmospheres of the test item with a MMAD of less than 4 μm. It was, therefore, considered appropriate to terminate this study prior to the exposure of a group of animals.

The dust generation properties of tBA Clavulanate with a particle size of less than 4 μm were shown to be low. It was, therefore, considered not to be possible to generate an atmosphere with a satisfactory particle size from the test item, for use in an inhalation study. In view of the physical nature of the test item, its apparent low volatility and its’ tendancy to clump, it is considered unlikely to represent a significant hazard by the inhalation route.